CORE B. HEALTH EVENTS AND ENDPOINTS SUMMARY / ABSTRACT ASPREE ensured clinical rigor through the implementation of an endpoint confirmation process supported by comprehensive clinical document collection and adjudication by clinical experts. This process resulted in the collection and successful adjudication of 8286 clinical endpoint triggers with analysis of these endpoints revealing novel insights about the effect of LDA in an older population, a proportion of whom developed mild cognitive impairment and dementia. Core B will be responsible for the responses to triggers for dementia assessment, such as decline in the 3MS, which lead to a staged process of collecting additional neurocognitive data including the ADAS-COG, functional information, neuroimaging, clinical assessments and laboratory results. Clinical experts then adjudicate cases according to DSM-IV dementia criteria and sub-classify ADRD (Alzheimer?s disease (AD) and related dementia) using NIA-AA criteria into probable AD, possible AD, mixed AD, unlikely AD or vascular dementia. To enable further discovery as part of this U19, Core B will build on the success of ASPREE by processing and adjudicating all key endpoints required for determination of the legacy effects of aspirin, including on cancer and dementia, and the trajectory of initially healthy individuals through the latter years of their lives. Meeting this overall aim requires the provision of high quality clinical data for analyses to assess change in benefit versus risk after aspirin use and specifically on the key health endpoints over the longer term. This Core will receive cancer, dementia, disability, death, cardiovascular disease, stroke and major hemorrhage triggers from completion of study assessments (Core A), medical record review (Core A) and data linkage with National Death Index and other government bodies (Admin Core). Core B will utilize the hub of endpoint coding and clinical document expertise developed during ASPREE to: i) review and code triggers based upon endpoint definitions; ii) collect key clinical information from health records and; iii) prepare case summaries for adjudication. Seven Endpoint Adjudication Subcommittees (sub-EACs) will adjudicate specific events (i.e. cancer, dementia, disability, cardiovascular disease, stroke, major hemorrhage and death) and report via their Chairs to a parent Endpoint Adjudication Committee that holds responsibility for clinical oversight of the adjudication process. Outcomes of adjudication will be entered into AWARD-Adjudicator (Core C) and made available for analyses via the Safe Haven data sharing biostatistics platform (Core C). Thus, through the conduct of additional dementia-specific cognitive, anatomical (neuroimaging) and functional assessments from participants and relevant health records holders for dementia endpoints along with the careful ascertainment of all other clinical endpoints, Core B will provide crucial links between the collection of raw clinical data (Core A), and the storage of clinical outcome information, data management and analyses for all projects (Core C). Consequently, Core B fulfils a vital clinical quality control function within this U19 and is essential for integrity of health outcome analysis.